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This document specifies requirements and test methods for Needle-Based Injection Systems (NISs) for single-patient use intended to deliver discrete volumes (bolus) of medicinal product, which can be delivered through needles or soft cannulas for intradermal, subcutaneous and/or intramuscular delivery, incorporating pre-filled or user-filled, replaceable or non-replaceable containers. This…

This document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1. It is applicable to single and multi-dose containers either filled by the manufacturer (primary container closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are…

This document specifies requirements and test methods for automated functions in needle-based injection systems with automated functions (NIS-AUTO). General requirements are provided for all automated functions. In addition, specific requirements are provided for the following automated functions: a) medicinal product preparation (e.g. reconstitution); b) needle preparation; c) needle hiding; d)…

This document specifies requirements and test methods for On-Body Delivery Systems (OBDS) needle-based injection systems (NISs) for single patient use, intended for subcutaneous, intramuscular or intradermal delivery of a discrete volume (bolus) of medicinal product, through needles or soft cannulas, incorporating pre-filled or user-filled, replaceable or non-replaceable containers. NOTE 1  …

fireplaces and appliances intended to be vented through the throat of a masonry fireplace. These appliances are designed for burning solid fuels such as wood and coal. 1.2 This Standard covers catalytic combustors utilized with fireplace inserts. 1.3 Fireplace inserts and hearth-mounted stoves as covered by this standard are not certified for installation in factory-built fireplaces within…

1.1 La présente norme s’applique aux poêles sur socle et aux foyers encastrables préfabriqués pour les foyers en maçonnerie et les appareils dans lesquels l’évacuation d’air se fait par la gorge du foyer en maçonnerie. Ces appareils sont conçus pour brûler des combustibles solides comme du bois et du charbon. 1.2 Cette norme porte sur les chambres de combustion catalytiques utilisées avec les…

1.1 These requirements apply to Factory-Built Type A Chimneys, which do not require field fabrication. The chimneys are typically intended for use with gas and liquid fuel-fired residential appliances and building heating equipment, where the appliance or equipment flue-gas temperatures do not exceed 540 °C. 1.2 The chimneys are typically intended for use in accordance with regulatory Codes,…

1.1 Ces exigences s’appliquent aux cheminées préfabriquées de type A qui ne nécessitent aucune fabrication de pièce sur le terrain. Les cheminées sont généralement destinées aux appareils résidentiels et aux installations de chauffage de bâtiment utilisant des combustibles gazeux et liquides dont la température des gaz de combustion n’excède pas 540 °C. 1.2 Les cheminées sont généralement…

1.1 These requirements apply to factory-built chimney assemblies which do not require field fabrication. 1.2 The factory-built chimney assemblies are for use with gas, liquid and solid fuel-fired residential appliances and building heating equipment, where the flue-gas temperatures normally do not exceed 650 ºC. 1.3 The factory-built chimney assemblies are intended for installation and use in…

1.1 Ces exigences s’appliquent aux cheminées préfabriquées qui ne nécessitent aucune fabrication de pièce sur le terrain. 1.2 Les cheminées préfabriquées sont destinées aux appareils résidentiels et aux installations de chauffage de bâtiment utilisant des combustibles gazeux, liquides ou solides dont la température des gaz de combustion n’excède habituellement pas 650 °C. 1.3 Les cheminées…